CDC Prepares for Possible Flu Vaccine Shortage in Upcoming Season
The federal government will begin the 2005-2006 flu season this fall by recommending vaccination only for high-risk U.S. residents, after which it will broaden the recommended population if enough doses remain, federal officials said Wednesday at a hearing of the House Energy and Commerce Subcommittee on Oversight and Investigations, the AP/Long Island Newsday reports (Neergaard, AP/Long Island Newsday, 5/4). Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, testified that flu vaccine manufacturer Chiron "has made significant progress" in its efforts to reopen its Liverpool, England, manufacturing facility, which was shuttered by the British Medicines and Healthcare Products Regulatory Agency in October 2004 over concerns about contamination (McKay/Chase, Wall Street Journal, 5/5). As a result, Chiron was unable to produce about half of the United States' 100 million-dose flu vaccine supply for the 2004-2005 season as expected (California Healthline, 4/6).
British regulators have given Chiron approval to begin producing vaccine at the plant again (Clarke, Los Angeles Times, 5/5). However, Goodman said that it is "too early" to determine whether FDA will grant Chiron approval to manufacture vaccines for the U.S. supply, and a final decision will not be made until after regulators complete an inspection of the Liverpool facility when it becomes fully operational in early summer (Wall Street Journal, 5/5). "What we're seeing is a lot of change, a lot of change in the right direction," Goodman said, adding that "the rubber has to meet the road on manufacturing" (CQ HealthBeat, 5/4).
Federal officials said they are optimistic that the United States will not face another flu-vaccine shortage this year, but because of the continued uncertainty over supply, CDC is developing contingency plans (CongressDaily, 5/5). CDC Director Julie Gerberding said the agency is making plans for three different scenarios. Under the best case scenario, the United States would receive 98 million doses -- the most flu vaccine ever available on the U.S. market. That total would include vaccine from Chiron, Sanofi Pasteur, MedImmune and GlaxoSmithKline (CQ HealthBeat, 5/4).
If Chiron's manufacturing process is approved by U.S. regulators, it could provide about 25 million doses. Sanofi-Pasteur, the nation's leading flu shot provider, plans to provide 50 million to 60 million doses, and MedImmune will likely provide three million doses of its nasal-spray vaccine. In addition, GSK, which provides flu vaccines to other nations, is seeking approval from FDA to sell 10 million doses of its product in the United States. Under the worst-case scenario, only 53 million doses of vaccine would be available, fewer than the 60 million that were available this year.
CDC officials say that a middle scenario -- under which 75 million to 83 million doses are available -- is the most likely (AP/Long Island Newsday, 5/4). Under that scenario, CDC "will start the flu season with a focus on high-risk people" and then offer the vaccine to lower-priority groups once the high-risk group's needs have been met, Gerberding said, adding that the lower-priority groups could begin receiving the vaccine as early as October or November. Gerberding also said that even under the worst-case scenario, "we do feel like our most vulnerable people will have a pretty good chance of getting vaccine."
In addition, CDC is spending $30 million for an emergency stockpile of investigational vaccines in case the United States runs short of regular vaccine supplies, she said (Wall Street Journal, 5/5). Meanwhile, Jeanne Santoli, an immunization expert at CDC, cited "unprecedented" demand for flu vaccine this year. According to the Journal, the "rush" to order flu vaccine this year "underscores lingering frustration among health care providers who had to turn away patients" in the most recent season because of the shortage and "shows that the vaccine production infrastructure remains nearly as fragile and outdated" as before the shortage (McKay/Naik, Wall Street Journal, 5/4).
The federal government is taking a number of steps to improve the United States' vaccine-production system and encourage vaccine manufacturers to modernize their process for making vaccines, Bruce Gellin, director of the HHS National Vaccine Program Office, said (Wall Street Journal, 5/5). Efforts include stockpiling vaccine in new ways, working more closely with foreign regulators to monitor manufacturers and encouraging additional manufacturers to enter the U.S. market (AP/Long Island Newsday, 5/4).
The government also is working with the manufacturers to invest in newer technologies to improve and speed vaccine production, which currently takes months. So far, the program has invested $99 million in the efforts this year, and officials have proposed another $120 million for the purpose in the fiscal year 2006 federal budget, Gellin said (Wall Street Journal, 5/5). Goodman said, "It would be ideal to have a vaccine that protects against multiple strains, ... but the science isn't there yet." According to the Times, researchers currently are working to develop a vaccine that targets one aspect of a virus that is present in all flu strains. Such a vaccine could "allay fears of a severe outbreak" such as the flu pandemic of 1918, which killed 40 million people worldwide. Gerberding said that there have been three pandemics in the United States in the last century (Los Angeles Times, 5/5).
Separately, in an editorial in the New England Journal of Medicine, Michael Osterholm -- director of the Center for Infectious Disease Research and Policy at the University of Minnesota -- said more needs to be done to prepare for the possibility of a flu pandemic. The editorial calls for a large-scale effort to prepare for the medical and economic consequences of the next worldwide flu pandemic, the Journal reports (Wall Street Journal, 5/5). According to Osterholm, a flu pandemic is inevitable, and a worldwide outbreak of the H5N1 avian flu virus in Asia "could rival" the pandemic of 1918 (Uhlman, Philadelphia Inquirer, 5/5).
CDC estimates that in the United States alone, up to 200 million residents could be infected, and between 88,000 and 300,000 could die (Philadelphia Inquirer graphic, 5/5). The United States could mitigate the effects of such a pandemic if it acts now to improve its planning, Osterholm says, noting that current medical supplies and methods for producing vaccine fall short of what would be needed to launch a full-scale attack on a pandemic flu (Philadelphia Inquirer, 5/5). "The current system of producing and distributing influenza vaccine is broken, both technically and financially," Osterholm wrote, adding, "We need to develop a new way to bring the private sector to the table with flu vaccine" (Wall Street Journal, 5/5).
Osterholm said the goal of improvement efforts should be the development of cell-based cultures that could protect against all types of influenza. He also called for the development of detailed plans by school boards, businesses and local governments to prepare for dealing with a pandemic flu and decide how to allocate resources. "I am not trying to scare people out of their wits. I am trying to scare them into their wits," Osterholm said.
"It is a very high-profile call to arms," Neil Fishman, director of infection control at the University of Pennsylvania Health System, said, adding, "We are unprepared."
Eddy Bresnitz, New Jersey's state epidemiologist, said, "People shouldn't expect the public-health knights to ride in on white horses from the state or federal level." He added, "I don't think we can wholesale prevent a pandemic. [But] we can prepare ourselves better to mitigate the impact."
John Kelly, chief medical officer at Pennsylvania-based Abington Memorial Hospital, warned that hospitals would be overwhelmed in the event of a pandemic. "The desire to reduce health care costs has taken the fat and the meat," he said, adding, "We are now down to the bone" (Philadelphia Inquirer, 5/5). The editorial is available online.